# JOM: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

- Device class: 2; regulation: 21 CFR 870.2780; FDA's rule: 510(k) required
- FDA decisions: 53
- 510(k) review time 2021–2025: median 238 days (middle half 192–299)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 2
- 2011: 1
- 2012: 1
- 2013: 2
- 2015: 2
- 2017: 1
- 2018: 1
- 2020: 2
- 2021: 1
- 2022: 2

## Most-cited predicates
- K023238: Mcpulse (2003), cited by 6
- K853124: Novametrix Pulse Oximeter, Model 500 (1985), cited by 3
- K042616: Biomedix Padnet Lab (2004), cited by 3
- K143152: TM-ABI system (2015), cited by 2
- K083735: Ansha Autonomic Nervous System Health Assessment Plus (2009), cited by 2
- K172655: Automated ankle brachial pressure index measuring device (2018), cited by 2
- K782132: Plethysmograph, Strain Gauge (1979), cited by 1
- K093192: Flochec Photo Plethysmographic Device (2010), cited by 1
- K982707: EC6 Plethysmograph (1998), cited by 1
- K073323: SA-3000P (2007), cited by 1

Source page: https://510kreport.com/product-code/JOM
Data by year (CSV): https://510kreport.com/product-code/JOM.csv